Actively Recruiting
4-aminopyridine for Skin Wound Healing to Accelerate Wound Closure
Led by John Elfar · Updated on 2025-09-03
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Many people experience wounds that do not heal well or take a long time to heal, including both chronic and acute wounds. This research aims to study the effects of 4-aminopyridine (4-AP), a drug currently used in neurological conditions, to see if it can help speed up wound healing in healthy adults. Previous animal studies showed promising results with faster healing and no adverse effects, making it important to evaluate 4-AP's role in human wound repair. Participants in this study will be randomly assigned to receive either 4-aminopyridine capsules or placebo capsules taken every 12 hours. The treatment period lasts for 6 weeks, during which researchers will monitor wound healing progress. The study includes a phase where participants receive either the active drug or placebo to compare effects on skin integrity and wound closure. During the study, participants will have a skin punch biopsy wound that will be monitored for healing over 6 weeks. Researchers will assess the return of skin integrity, wound closure, and hair growth at the biopsy site. Participants must attend scheduled follow-up visits and may be asked to provide wound photographs. The study also tracks safety and tolerability, ensuring participants are able to report any sensory or motor changes. Total participation is about 6 weeks with regular evaluations.
CONDITIONS
Brief Title
4-aminopyridine for Skin Wound Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Otherwise healthy without skin conditions affecting the axilla or upper inner arm
- Able to understand and report sensory and motor changes during wound examination
- Eligible for standard wound healing by secondary intention
- Able to give written informed consent
- Capable of attending all scheduled follow-up visits safely
You will not qualify if you...
- History of multiple sclerosis, stroke, or other neurological disorders
- Allergy or hypersensitivity to AMPYRA� or 4-aminopyridine
- Current use of aminopyridine medications including compounded 4-AP
- Suspected kidney impairment
- History of poor compliance with follow-up
- Outside age range of 18 to 70 years
- Unable to provide informed consent
- History of seizure disorder
- Traumatic brain injury
- Unable to communicate or unwilling to complete study requirements
- Taking organic cation transporter 2 (OCT2) inhibitors like Cimetidine
- Pregnancy, breastfeeding, or incarcerated
- Non-English speaking
- Unable or unwilling to provide calibrated wound photographs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either 4-aminopyridine or placebo capsules twice daily to promote skin wound healing.
Weekly visits for up to 6 weeks
Duration - Up to 6 weeks
Participants are monitored after treatment to assess wound closure and skin integrity.
1 to 2 visits
Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
A
Andrea Horne
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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